ASEAN Regional Integration Support from the EU

Workshop on the ASEAN Pharmaceutical Regulatory Framework

Members of the Pharmaceutical Product Working Group (PPWG) and the ASEAN Health Cluster 3 (AHC  3) made substantial progress on the development of the ASEAN Pharmaceutical Regulatory Framework. The two bodies have agreed that the draft document is now sufficiently developed to permit a final domestic consultation and pave the way for formal adoption.

The PPWG and AHC 3 represent Member States’ interest on the economic and health aspects of the pharmaceutical sector and are leading the development of a comprehensive market integration process for the pharmaceutical sector. The virtual event was held in 2 sessions on 7th & 8th December, 2021. This event follows the successful conclusion of deliberations on the ASEAN Pharmaceutical Regulatory Policy (APRP) by the same ASEAN bodies in October of this year.  The APRP itself is now under review by senior officials in the Economic and Health sectors preceding a formal adoption by ASEAN Member States.

The APRF elaborates on the governance, management structure, recognition, cooperation and coordination mechanisms that have to be developed to realise the targets of an integrated market. The stated objectives of the APRF is to assure the availability of quality, safe and efficacious pharmaceuticals across ASEAN.

Going forward it is planned, that discussions will lead a legally binding APRF Agreement.  This APRF Agreement will provide a structured approach that builds upon the existing initiatives in the sector; i.e. mutual recognition arrangements on Good Manufacturing Practice of and on Bioequivalence Study Reports of generic drugs and other harmonised technical requirements that have been developed by the PPWG and AHC 3 on the safety, quality, efficacy and access to pharmaceutical products. 

This development brings ASEAN Member States a step closer to the adoption of the APRF Agreement. The APRF Agreement will substantially elevate the pace of regulatory cooperation and enable achievement of long-term target for a structured development of the regulatory systems for pharmaceutical products in a harmonised manner in all ASEAN Member States.

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